Medline Kits Recall Due to Rescinded Regulatory Clearances
Medline Industries, LP is voluntarily recalling 3183 units of various medical kits across the United States because the regulatory clearances for certain components have been rescinded.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Medline Industries, LP is recalling certain medical kits due to the rescinded 510(k) regulatory clearances for components such as Control Syringes, Guidewires, and/or High-Pressure Tubing. This is a voluntary recall initiated by the firm.
Which Products Are Affected
The affected products include the following Medline Kits with their model numbers and specific lot numbers: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M, Lot Numbers: 23KBL880, 24ABA125, 23IBA898; 2) ANGIO PACK, Model Number: DYNJT2021G, Lot Number: 24CMH245; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B, Lot Numbers: 25LBQ639, 25GBF384; 4) ANGIO PACK, Model Number: DYNJ51279, Lot Numbers: 25DBQ486, 25CBT538; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447, Lot Number: 25FMA232; 6) CATH ANGIO PACK, Model Number: DYNJ53369C, Lot Numbers: 25ILA917, 25FLA554; 7) ANGIO PACK, Model Number: DYNJ53591A, Lot Number: 25FBA222; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516, Lot Numbers: 21JBN533, 21KBM563, 21KBQ110, 21LBI454, 23DMF559, 23EMB053, 23FME913, 23JME012, 24BMK272, 24CMK043, 24CMK043Z, 24DMJ156, 24FMI064, 24HMB643, 24JME212, 23HME551, 25DMB495; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A, Lot Number: 25GBS720; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742, Lot Number: 24KBE607; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876, Lot Number: 25KBP615; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A, Lot Number: 23GMC436. A total of 3183 units are affected, distributed nationwide in the United States. Specific UDI-DI codes are associated with each product, such as 10889942846900 for DYNJQ0505M.
What You Should Do
Consumers should not use the affected products and contact Medline Industries, LP for further instructions, as the recall was initiated via letter. For returns or refunds, reach out to the firm at their address: 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
This recall involves medical devices that could potentially affect patient safety due to the rescinded clearances, highlighting the importance of regulatory compliance in healthcare products. It impacts 3183 units distributed across the United States, potentially requiring users to seek alternatives to ensure proper medical procedures.
Source
This information is from the FDA recall database, attributed to recall number Z-1834-2026. For more details, visit the FDA website at https://www.fda.gov/.
Original source: FDA Official Notice ↗
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